Table 2.

Overview of selected cetuximab q1w dosing studies in which KRAS mutational status was assessed

Trial name and patient characteristics	Evaluable patients, n	Dose and treatment	KRAS status	ORR, %	Median PFS, mo	Median OS, mo
CRYSTAL: first-line mCRC29
	599	FOLFIRI + ctx q1w	Any	59.3	9.9	24.9
	599	FOLFIRI	Any	43.2	8.7	21.0
	172	FOLFIRI + ctx q1w	WT	59.3	9.9	24.9
	176	FOLFIRI	WT	43.2	8.7	21.0
	105	FOLFIRI + ctx q1w	Mut	36.2	7.6	17.5
	87	FOLFIRI	Mut	40.2	8.1	17.7
OPUS: first-line mCRC54
	169	FOLFOX4 + ctx q1w	Any	46	7.2	18.3
	168	FOLFOX4	Any	36	7.2	18.0
	82	FOLFOX4 + ctx q1w	WT	57	8.3	22.8
	97	FOLFOX4	WT	34	7.2	18.5
	77	FOLFOX4 + ctx q1w	Mut	34	5.5	13.4
	59	FOLFOX4	Mut	53	8.6	17.5
COIN: first-line mCRC52
	362	Chemotherapy* + ctx q1w	WT	64	8.6	17.0
	367	Chemotherapy*	WT	57	8.6	17.9
	297	Chemotherapy* + ctx q1w	Mut	NR	NR	13.6
	268	Chemotherapy*	Mut	NR	NR	14.8
NORDIC VII: first-line advanced/ mCRC53
	185	FLOX	Any	41	7.9	20.4
	194	FLOX + ctx q1w	Any	49	8.3	19.7
	97	FLOX	WT	47	8.7	NR
	97	FLOX + ctx q1w	WT	46	7.9	NR
	58	FLOX	Mut	40	7.8	NR
	72	FLOX + ctx q1w	Mut	49	9.2	NR
MABEL: second-line. Previously failed irinotecan-based therapy50
	93	Irinotecan q1w + ctx q1w	Any	18.3	3.0	8.3
	670	Irinotecan q2w + ctx q1w	Any	17.3	3.2	9.2
	356	Irinotecan q3w + ctx q1w	Any	25.8	4.6	10.3
	28	Irinotecan other + ctx q1w	Any	21.4	2.7	7.0
	1147	Irinotecan (all) + ctx q1w	Any	20.1	3.2	9.2
EPIC: second-line. Previously failed oxaliplatin and fluoropyrimidine49
	648	Irinotecan + ctx q1w	Any	16.4	4.0	10.7
	650	Irinotecan	Any	4.2	2.6	10.0
BOND: advanced CRC. PD during or within 3 months of irinotecan treatment46
	218	Irinotecan + ctx q1w	Any	22.9	4.1†	8.6
	111	Ctx q1w	Any	10.8	1.5†	6.9
CO.17: CRC. Previously treated with fluoropyrimidine, irinotecan, and oxaliplatin and no other standard therapy available47,48
	287	Ctx q1w	Any	8	1.9	6.1
	285	BSC	Any	0	1.8	4.6
	117	Ctx q1w	WT	12.8	3.7	9.5
	113	BSC	WT	0	1.9	4.8
	81	Ctx q1w	Mut	1.2	1.8	4.6
	83	BSC	Mut	0	1.8	4.5

BSC = best supportive care; CRC = colorectal cancer; Ctx = cetuximab; FLOX = fluorouracil + leucovorin + oxaliplatin; FOLFIRI = 5-flurouracil + leucovorin + irinotecan; FOLFOX = 5-fluorouracil + leucovorin + oxaliplatin; mCRC = metastatic colorectal cancer; Mut = KRAS mutant; NR = not reported; OS = overall survival; ORR = overall response rate; PD = progressive disease; PFS = progression-free survival; q1w = every week; WT = wild-type.

^*Oncologists could choose XELOX (capecitabine + oxaliplatin) or FOLFOX.

^†Reported as time to progression.